Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

This open-label pilot study (n=5) aims to investigate whether a two-part outpatient procedure, utilising a modified ketogenic diet followed by a series of titrated ketamine infusions, can lead to improvements or remission of chronic anorexia nervosa in adults who have experienced symptoms for at least three years despite undergoing treatment involving at least two different modalities.

The study, sponsored by Homeostasis Therapeutics, LLC, is conducted in South Windsor, Connecticut, United States, and led by Principal Investigator Lori Calabrese, MD from Innovative Psychiatry. The study started on April 12, 2021, and concluded on July 26, 2022, with an enrollment of 5 participants.

Participants undergo a two-day immersive educational program to initiate the modified ketogenic diet, followed by a four-week period of adopting the diet at home, with regular follow-up. This is followed by a series of titrated intravenous ketamine infusions scheduled over two weeks. Throughout the study, various objective and psychological measures assess safety and response, with participants being monitored for 12 months.

Topic Eating Disorders
Compound Ketamine
Country United States of America
Visit trial
Status Completed
Results Published No
Start date 12 April 2021
End date 26 July 2022
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 5
Sex All
Age 18- 65
Therapy No

Trial Details

This Open-Label Pilot Study Aims to Determine Whether a Two-Part Sequenced Out Patient Procedure Utilizing a Modified Ketogenic Diet Followed by a Series of Titrated Ketamine Infusions Results in Improvement or Remission of Chronic Anorexia Nervosa in Adults with Symptoms of Anorexia for at Least 3 Years Despite Treatment Involving at Least 2 Different Modalities. The Hypothesis is That the Diet Addresses Core Metabolic Deficits in the "Anorexic Brain" and Primes the Response to Ketamine.

NCT Number NCT04714541

Sponsors & Collaborators

Homeostasis Therapeutics
Homeostasis Therapeutics is a pioneering company dedicated to revolutionizing the treatment of anorexia nervosa.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.